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510(k) K020618

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL by Aalto Scientific, Ltd. — Product Code GLK

K020618 is an FDA 510(k) premarket notification submitted by Aalto Scientific, Ltd. for the device "AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625. Aalto Scientific, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
February 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hematocrit
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Aalto Scientific, Ltd.

  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K143571 — Audit MicroControls Linearity LQ Cystatin-C (January 23, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (November 21, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)
  • K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (April 29, 2013)
  • K130764 — AUDIT MICROCV VITAMIN D LINEARITY SET (April 26, 2013)
  • K130157 — AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (March 19, 2013)
  • K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL (June 15, 2012)

Other clearances for product code GLK

  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K021924 — MEDICA EASYQC HEMATOCRIT CONTROL (June 24, 2002)
  • K964452 — HEMATACHEK (February 20, 1997)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K924926 — MSI-HCT (January 7, 1993)
  • K893562 — A.QC HCT LEVEL 1 AND 2 (July 14, 1989)

FDA data resources